Little Progress Made in Insuring Patient Safety

Action Points

Point out that this study was conducted in only one state, although that state has a reputation for being especially proactive regarding patient safety.

A decade after the Institute of Medicine's report cataloging iatrogenic injury, harm resulting from medical care is still common with few signs of improvement, at least at 10 North Carolina hospitals, researchers found.

Over a six-year period, internal reviewers identified 588 instances of patient injury among 2,341 admissions, for a rate of 25.1 per 100 admissions, according to Christopher Landrigan, MD, MPH, of Brigham and Women's Hospital in Boston, and colleagues.

The rate of overall harms -- and of those deemed to be preventable -- did not change over the study period, the researchers reported in the Nov. 25 issue of the New England Journal of Medicine.

"Though disappointing, the absence of apparent improvement is not entirely surprising," they wrote. Despite enhanced attention on patient safety following the 1999 Institute of Medicine report on medical errors, "the penetration of evidence-based safety practices has been quite modest."

For example, Landrigan and his colleagues pointed out, only 1.5% of hospitals in the U.S. have implemented a comprehensive system of electronic medical records.

"Although the absence of large-scale improvement is a cause for concern, it is not evidence that current efforts to improve safety are futile," they argued.

"On the contrary, data have shown that focused efforts to reduce discrete harms, such as nosocomial infections and surgical complications, can significantly improve safety."

Landrigan and his colleagues retrospectively reviewed medical records from a random sample of 10 hospitals in North Carolina. That state was chosen because it has been highly involved in efforts to improve patient safety.

The analysis included information about 2,341 adults discharged from 2002 through 2007. Each record was examined by teams of nurse reviewers from both within and outside the hospitals for evidence of harm using the Institute for Healthcare Improvement's Global Trigger Tool for Measuring Adverse Events. Two independent physician reviewers confirmed any suspected cases.

Of the 588 instances of harm identified by internal reviewers, 63.1% were classified as preventable.

Injuries involved procedures in 186 cases, medications in 162, nosocomial infections in 87, other therapies in 59, diagnostic evaluations in seven, and falls in five; other causes accounted for the rest.

The majority of the adverse events (about 84.4%) were temporary, requiring either intervention or initial or prolonged hospitalization, although 8.5% were life-threatening, 2.9% were permanent, and 2.4% caused or contributed to death.

There were no significant changes in the rate of overall harms identified by internal review, or in the rate of preventable harms, over time, either before or after multivariate adjustment.

External reviewers identified fewer cases of harm than did internal reviewers. Considering these cases, there was no change over time in the rate of overall harms either.

However, before adjustment, there was a reduction in the rate of preventable harms identified by external review, from 23.5 per 1,000 patient-days in 2002 to 15.0 per 1,000 patient-days in 2007 (P=0.04). The difference fell short of statistical significance -- with a P-value of 0.06 -- after accounting for demographics, hospital service, and high-risk conditions.

"The finding in this study of reductions in preventable harms (though not total harms) of borderline statistical significance on the basis of external reviews suggests the possibility that some improvements are beginning to occur, though further longitudinal studies using robust methods will be needed to determine whether this is, in fact, the case," the researchers wrote in their paper.

They acknowledged some limitations of the study including the fact that North Carolina may not be representative of the entire country and the 10 hospitals may not be representative of all of those in the state.

They also acknowledged that any record review is limited to the information provided in the record, and that the study was powered to detect a change in overall harms, not preventable harms.

The study was supported by a grant from the Rx Foundation.

Landrigan reported receiving money personally and through his institution from the Rx Foundation. He also reported receiving money for travel support from the Institute for Healthcare Improvement, Vital Issues in Medicine, and Associated Professional Sleep Societies, and honoraria and travel support for lectures from the NIH, University of Texas, Committee of Interns and Residents, Warwick Medical School, California Association of Neonatologists, Children's Hospitals and Clinics of Minnesota, Children's Hospital at Montefiore, 7th National Advance Practice Neonatal Nurses Conference, and St. Louis Children's Hospital.

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